Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients

• Conditions: Breast Neoplasm Female; Advanced Breast Cancer; Surgery
• Interventions: Procedure: Locoregional surgery

• Registration Number: NCT04456855
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

Current guidelines lack definitive evidences about the relative benefits of locoregional surgery for the primary tumor in de novo stage IV breast cancer. The aim of this study (SYSBTC-001) was to investigate the role of locoregional surgery for primary tumor in de novo stage IV breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-01
• Last Update Submitted: 2020-07-01
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07
• Primary Completion: 2020-10-30
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 358

Inclusion Criteria

• Operable stage IV breast cancer patients,whose primary lesion is invasive breast cancer confirmed by pathology, and metastases can be confirmed by pathology or imageology examination.
• ECOG-PS 0-2.
• Bone marrow, liver and kidney should be fully functional.
• Patients received the locoregional surgery of the primary tumor in de novo in our center, or didn't received the locoregional surgery of the primary tumor in de novo.
• For the patient who accepted systematic treatment before operation, the systematic treatment must be administered within a year since diagnosed.

Exclusion Criteria

• Accompanied with other primary malignant tumors.
• Patients who can't plan for follow-up effectively and regularly.
• Multiple liver metastasis and ALT/AST four times higher than normal at patients' first diagnosis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Locoregional surgery	Locoregional surgery	-

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years	The association between locoregional surgery and overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.

Secondary Outcome Measures

Name	Time	Method
Locoregional progression free survival	5 years	Defined as time between the time of diagnosis and the time of locoregional recurrence, or death occurred.
Distant progression free survival	5 years	Distant disease free survival (D-DFS), which defined as the time from the diagnosis of de novo stage IV breast cancer to the confirmed time of distant progression, or death due to any other cause.

Trial Locations

Locations (3)

First People's Hospital of Foshan; 🇨🇳 Foshan, Guangdong, China

Sun Yat-Sen Memorial Hospital of Sun Yat-sen; 🇨🇳 Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China